Agency Information Collection Activities: Proposed Collections; Comment Request; Reinstatements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N-0454]

Agency Information Collection Activities: Proposed Collections;

Comment Request; Reinstatements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish a notice in the

Federal Register concerning each proposed collection of information,

including each proposed reinstatement of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on provisions related to

investigational device exemptions (IDE) reports and records;

requirements for premarket notifications and summaries filed under the

Federal Food, Drug, and Cosmetic Act (the act); and reporting and

recordkeeping requirements imposed on entities that have had products

detained during an establishment inspection that are believed to be

adulterated or misbranded, or have had products banned.

DATES: Submit written comments on the collections of information by

March 24, 1997.

ADDRESSES: Submit written comments on the collections of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should

be identified with the docket number found in brackets in the heading

of this document.

FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,

301-827-1479.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed reinstatement of an existing collection of information,

before submitting the collection to OMB for approval. To comply with

this requirement, FDA is publishing notice of the proposed collections

of information listed below.

With respect to each of the following collections of information,

FDA invites comments on: (1) Whether the proposed collections of

information are necessary for the proper performance of FDA's

functions, including whether the information will have practical

utility; (2) the accuracy of the agency's estimates of the burdens of

the proposed collections of information, including the validity of the

methodologies and assumptions used; (3) ways to enhance the quality,

utility, and clarity of the information to be collected; and (4) ways

to minimize the burdens of the collections of information on

respondents, including through the use of automated collection

techniques, when appropriate, and other forms of information

technology.

1. Investigational Device Exemptions Reports and Records (Part 812

(21 CFR Part 812)) (OMB Control Number 0910-0078--Reinstatement)

This information is collected under the statutory authority of the

act regarding investigational devices (section 520(g) (21 U.S.C.

360j(g))). An IDE allows a device, which would otherwise be subject to

provisions of the act such as premarket notification or premarket

approval, to be used in

[[Page 3294]]

investigations involving human subjects in which the safety and

effectiveness of the device is being studied. The purpose of this

section, as explained in Sec. 812.1, is to encourage, to the extent

consistent with the protection of public health and safety and with

ethical standards, the discovery and development of useful devices

intended for human use. Under Secs. 812.20, 812.25, and 812.27,

information collected in the application includes sponsor information;

a report of prior investigations including reports of all prior

clinical, animal, and laboratory testing of the device, a bibliography

of all publications, and a summary of all other unpublished

information; an investigational plan including study, purpose,

protocol, risk analysis, device description, and monitoring procedures;

a description of the methods, facilities, and controls used for the

manufacture, processing, packing, and storage of the device;

investigator information including agreements and certifications;

institutional review board (IRB) information; information on the amount

to be charged for the device; device labeling; and informed consent

materials.

Section 812.10 (waiver of IDE requirements) states that if a

sponsor does not wish to comply with certain requirements of part 812,

the sponsor may voluntarily submit a waiver request.

Under Sec. 812.35, when an investigational plan changes, a sponsor

is required to submit a supplemental application to FDA, and the

sponsor may not begin a part of an investigation at a facility until

the IRB has approved the investigation, FDA has received the

certification of IRB approval, and FDA has approved the supplemental

application relating to that part of the investigation.

Section 812.140 requires investigators to maintain records,

including correspondence and reports concerning the study; records of

receipt, use or disposition of devices; records of each subject's case

history and exposure to the device; informed consent documentation;

study protocol and documentation of any deviation from the protocol.

Sponsors are required, under the same section, to maintain records

including correspondence and reports concerning the study; records of

shipment and disposition; signed investigator agreements; adverse

device effects information; and, if of nonsignificant risk, an

explanation of nonsignificant risk determination, records on device

name and intended use, study objectives, investigator information, IRB

information, and statement on the extent that good manufacturing

practices will be followed.

Section 812.150 requires investigators to submit reports on

unanticipated adverse device effects, withdrawal of IRB approval,

progress reports, deviations from investigational plan, failure to

obtain informed consent, and final report. Sponsors are required to

submit reports on unanticipated adverse device effects, withdrawal of

IRB approval, withdrawal of FDA approval, current investigator lists,

progress reports, notification of recall and device disposition, final

report, failure to obtain informed consent, and significant risk device

determination.

The following parts of the IDE regulations are covered by other

sections of part 812, and thus are not mentioned as separate reporting

or recordkeeping burden requirements. The requirements for Sec. 812.18

(import and export requirements for IDE's) are already covered under

Sec. 812.20(b)(1). Section 812.18 states that foreign companies are

required to be sponsored by a U.S. agent, whose identity is required

under the IDE application. This is not an additional information

collection, and a separate requirement for information is not essential

just because this is an imported device. Sections 812.40, 812.45, and

812.46, regarding the general responsibilities of sponsors, are

described under Secs. 812.20 (actual application) and 812.150

(recordkeeping).

Section 812.5 (the labeling of investigational devices) is included

under Sec. 812.20(b)(10), where the submitter is required to enclose a

copy of the label that bears information required by Sec. 812.5 (i.e.,

name and place of business of manufacturer, packer, or distributor, the

quantity of contents if appropriate, and the following statement:

``CAUTION-Investigational device. Limited by Federal (or United States)

law to investigational use''). This label shall describe all relevant

contraindications, hazards, adverse effects, interfering substances or

devices, warnings, and precautions. The label will also not bear any

statement that is false or misleading in any particular and shall not

represent that the device is safe or effective for the purposes for

which it is being investigated. If the device is being used solely for

animal research, the label shall bear the following statement:

``CAUTION-Device for investigational use in laboratory animals or other

tests that do not involve human subjects.'' This section's burden is

required under Sec. 812.20(b)(10), therefore a separate burden estimate

is not required.

This information will allow FDA to collect data to ensure that the

use of the device will not present an unreasonable risk for the subject

enrolled in the study and will not violate the subject's rights.

The likely respondents to this information collection will

primarily be medical device manufacturers, investigators, hospitals,

health maintenance organizations, and businesses.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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812.10 (waiver requests) 0.0 0.0 0.0 0.501 0.12

812.20, 812.25, and 812.27

(original application) 500 0.428 214 80 17,120

812.35 and 812.150 (amendments

and supplements) 500 6.86 3,430 6 20,580

Total 37,700

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There are no capital costs or operating and maintenance costs associated with this collection of information.

1FDA's best estimate given the fact that no waiver request has ever been submitted.

2FDA's best estimate given the fact that no sponsor has submitted such a request between fiscal years 1991 and

1995.

Based on past conversations with manufacturers, industry and trade

association representatives, and businesses, FDA has estimated that the

annual reporting burden for one IDE original application takes

approximately 80 hours to complete, and the annual reporting burden for

one IDE amendment and supplement takes

[[Page 3295]]

approximately 6 hours to complete. The number of respondents who

annually respond to this collection of information has decreased from

700 to 500, due to multiple applications received from each respondent.

Based on an average of IDE's submitted from fiscal years 1991

through 1995, approximately 500 respondents submit IDE applications

(originals and supplements) annually. Based on data from fiscal years

1991 to 1995, an average of 214 original IDE applications are submitted

annually.

The reporting burden for nonsignificant risk device studies is

negligible. Normally, nonsignificant risk device studies are not

reported to FDA unless a problem is reported such as an unanticipated

adverse device reaction, failure to obtain informed consent, withdrawal

of IRB approval, or a recall of a device. In the past, an average of 10

incidences or less annually have been reported to FDA.

Table 2.--Estimated Annual Recordkeeping Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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812.140 (original and

supplement) 500 0.428

6.86 214

3,430 10

1 2,140

3,430

812.140 (nonsignificant) 500 1 500 6 3,000

Total 8,570

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There are no capital costs or operating and maintenance costs associated with this collection of information.

Over the past several years, in conversations with manufacturers,

industry trade association groups, and businesses, FDA has estimated

that the recordkeeping burden for preparing an original IDE submission

averages 10 hours for each original IDE submission. Similarly, through

the same conversations mentioned above, FDA has estimated recordkeeping

for each supplement requires 1 hour.

The recordkeeping burden for nonsignificant risk device

investigations is difficult to estimate because nonsignificant risk

device investigations are not required to be submitted to FDA. The IDE

staff estimates that the number of nonsignificant risk device

investigations is equal to the number of active significant risk device

investigations. The recordkeeping burden, however, is reduced for

nonsignificant risk device studies.

2. Information Required In A Premarket Notification Submission (21

CFR 807.87, 807.92, and 807.93) (OMB Control Number 0910-0281--

Reinstatement)

Under section 510 of the act (21 U.S.C. 360), a premarket

notification must be filed before the introduction or delivery for

introduction of a device intended for human use. Under Sec. 807.87 (21

CFR 807.87), premarket notifications are required to contain certain

information, including the device name, establishment registration

number, class of the device, the device's proposed labeling, action

taken by the person required to register to comply with performance

standards, and a 510(k) summary as described in 21 CFR 807.92 or a

510(k) (of the act) statement as described in Sec. 807.93 (21 CFR

807.93). In addition, Sec. 807.87(i) requires that those filing

premarket notification who claim substantial equivalence to certain

devices as described in Sec. 807.87(i), that are classified into class

III, must submit to FDA a summary of safety and effectiveness problems

and a citation to the information upon which the summary is based. The

premarket notification submitter must also furnish FDA with a

certification that a reasonable search has been conducted of all known

information.

The information collected in the premarket notification is

necessary to enhance FDA's ability to ensure that only premarket

notification submissions for devices that are as safe and as effective

as legally marketed predicate devices are cleared for marketing. In

addition, FDA makes publicly available this information concerning

devices for which a marketing order has been issued, in order to

provide to the public the agency's basis for equivalence

determinations.

Respondents to this collection of information are medical device

manufacturers and distributors.

FDA estimates the burden of this collection of information as

follows:

Table 3.--Estimated Annual Reporting Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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807.87(h) and 807.92 (simple

510(k) summaries) 2,592 1 2,592 8 20,736

807.87(h) and 807.92 (complex

510(k) summaries) 247 1 247 12 2,964

807.87(h) and 807.93 (510(k)

statements) 2,896 1 2,896 1 2,896

807.87(i) and 807.94

(certifications) 208 1 208 40 8,320

Total 34,916

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There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases these estimates on conversations with industry and trade

association representatives, and from internal review of the documents

listed in the table above.

Under Sec. 807.93, anyone submitting a 510(k) statement must make

that information available to anyone who requests it.

[[Page 3296]]

Table 4.--Estimated Annual Recordkeeping Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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807.93 2,896 10 28,960 0.5 14,480

Total 14,480

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There are no capital costs or operating and maintenance costs associated with this collection of information.

3. Administrative Detention and Banned Medical Devices (21 CFR

800.55, 800.55(k), 895.21, and 895.22) (OMB Control Number 0910-

0114--Reinstatement)

FDA has the statutory authority under section 304(g) of the act (21

U.S.C. 334(g)), to detain during establishment inspections devices that

are believed to be adulterated or misbranded. On March 9, 1979, FDA

issued a final regulation on administrative detention procedures, which

includes, among other things, certain reporting requirements

(Sec. 800.55(g) (21 CFR 800.55(g))) and recordkeeping requirements

(Sec. 800.55(k)). Under Sec. 800.55(g), an applicant of a detention

order must show documentation of ownership if devices are detained at a

place other than that of the appellant. Under Sec. 800.55(k), the owner

or other responsible person must supply records about how the devices

may have become adulterated or misbranded, as well as records of

distribution of the detained devices. These recordkeeping requirements

for administrative detentions allow FDA to trace devices for which the

detention period expired before a seizure is accomplished or injunctive

relief is obtained.

FDA also has the statutory authority under section 516 of the act

(21 U.S.C. 360f) to ban devices that present substantial deception or

an unreasonable and substantial risk of illness or injury. The final

regulation for banned devices contains certain reporting requirements

(Secs. 895.21(d) and 895.22(a) (21 CFR 895.21(d) and 895.22(a))).

Section 895.21(d) states that if the Commissioner of Food and Drugs

(the Commissioner) decides to initiate a proceeding to make a device a

banned device, a notice of proposed rulemaking will be published in the

Federal Register, and this notice will contain the finding that the

device presents a substantial deception or an unreasonable and

substantial risk of illness or injury. The notice will also contain the

reasons why the proceeding was initiated, an evaluation of data and

information obtained under other provisions of the act, any

consultations with the panel, and a determination as to whether the

device could be corrected by labeling or change of labeling, or change

of advertising, and if that labeling or change of advertising has been

made. Under Sec. 895.21(d), any interested person may request an

informal hearing and submit written comments. Under Sec. 895.22, a

manufacturer, distributor, or importer of a device may be required to

submit to FDA all relevant and available data and information to enable

the Commissioner to determine whether the device presents substantial

deception, unreasonable and substantial risk of illness or injury, or

unreasonable, direct, and substantial danger to the health of

individuals.

Respondents to this collection of information are those

manufacturers, distributors, or importers whose products FDA seeks to

detain or ban. As previously stated, the collection of data and

information under these regulations is conducted on a very infrequent

basis and only as necessary.

FDA estimates the burden of this collection of information as

follows:

Table 5.--Estimated Annual Reporting Burden\1\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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800.55(g) 1 1 1 25 25

895.21(d) and 895.22(a)\2\ 0 0 0 0 0

Total 25

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

\2\ No devices were banned during the past 3 years (Sec. Sec. 895.21 and 895.22). Therefore, no burden has

been imposed upon industry. When the prosthetic hair fibers were banned, there were no firms in the United

States that were manufacturing or distributing the products. Thus, FDA has put zeroes in the columns

estimating reporting and recordkeeping burdens.

Table 6.--Estimated Annual Recordkeeping Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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800.55(k) 1 1 1 20 20

Total 20

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There are no capital costs or operating and maintenance costs associated with this collection of information.

Over the past 3 years, there has been an average of one new

administrative detention action per year. Each administrative detention

will have varying amounts of data and information that must be

maintained.

FDA's estimate of the burden under the administrative detention

provision is based on FDA's discussion with one of the three firms

whose devices had been detained over the last 3 years.

[[Page 3297]]

Dated: January 15, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-1481 Filed 1-21-97; 8:45 am]

BILLING CODE 4160-01-F